SAFE SEA SPF 50 KIDS- homosalate, octocrylene, octisalate, avobenzone lotion

Safe Sea SPF 50 KIDS by

Drug Labeling and Warnings

Safe Sea SPF 50 KIDS by is a Otc medication manufactured, distributed, or labeled by SASA Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Octocrylene 10%

Homosalate 10%

Octisalate 5%

Avobenzone 3%

Purpose: Sunscreen

INACTIVE INGREDIENT

Inactive Ingredients: Aqua, Dibutyl Adipate, Polyglyceryl 2 Dipolyhydroxystearate, Stearyl Dimethicone, Cetyl Dimethicone, Magnesium Stearate, Hydrogenated Castor Oil, Benzyl alcohol, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Glycosaminoglycans, Glycoproteins, Plankton Extract, Parfum(Fragrance), Chlorphenisin, Panthenol, Tocopheryl Acetate, Dehydroacetic Acid, Benzoic Acid, Sorbic Acid

INDICATIONS & USAGE

Uses: ■ Helps prevent sunburn ■ If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer
and early skin aging caused by the sun.

WARNINGS

Warning: ■ For external use only ■ Do not use on damaged or broken skin ■ When using this product keep out of eyes. Rinse with water to
remove ■ Stop use and ask a doctor if rash occurs.

INSTRUCTIONS FOR USE

Directions: ■ Apply liberally 15 minutes before sun exposure ■ reapply: After 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours ■ Sun Protection Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: ■ Limit time in the sun, especially from 10 a.m.to 2 p.m.■ Wear long-sleeve shirts, pants, hats, and sunglasses ■ Children under 6 months: Ask a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

Other Information: ■ Give particular attention to coverage of arms and legs. ■ In water infested by Sea Lice, Safe Sea should also be applied
under the bathing suit.■ Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water,
nor is it a guarantee against stings.■ In case of sting do not use Safe Sea as a treatment - seek medical attention.*Tested against Sea nettle
(Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file. ■ Protect this product from excessive heat and direct sun.

Principal Display Panel

Front Label

Back Label

INGREDIENTS AND APPEARANCE

SAFE SEA SPF 50 KIDS  
homosalate, octocrylene, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66134-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LANTHANUM CHLORIDE (UNII: 04M8624OXV)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CHLORPHENESIN (UNII: I670DAL4SZ)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBIC ACID (UNII: X045WJ989B)
PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66134-001-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/06/2019

Labeler - SASA Cosmetics (600481230)

Registrant - SASA Cosmetics (600481230)

Establishment
Name	Address	ID/FEI	Business Operations
SASA Cosmetics		600481230	manufacture(66134-001)